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FDA 510(k)

Tech Dots - Adhesive and conductive gel

K-Number: K190050 · 2019-07-19

ApplicantSpes Medica Srl
Decision Date2019-07-19
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Tech Dots - Adhesive and conductive gel is the device name listed in this FDA 510(k) record. The listed applicant is Spes Medica Srl. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K190050. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tech Dots - Adhesive and conductive gel?

Tech Dots - Adhesive and conductive gel is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Spes Medica Srl. The 510(k) number is K190050.

When did Tech Dots - Adhesive and conductive gel receive FDA 510(k) clearance?

Tech Dots - Adhesive and conductive gel received FDA 510(k) clearance on 2019-07-19, under 510(k) number K190050.

Who is the listed applicant for Tech Dots - Adhesive and conductive gel?

The FDA 510(k) record lists Spes Medica Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tech Dots - Adhesive and conductive gel?

The FDA product code for Tech Dots - Adhesive and conductive gel is GYB.

Other records listing Spes Medica Srl as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.K222770Conductive GelTop-Rank Health Care Co., Ltd.K221724Conductive GelTone-A-Matic International, Inc.K212325EEG-acpSomnomedics GmbHK212326AC Cream - Conductive pasteSpes Medica Srl

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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